Metabolic Syndrome. Metabolic disorder, unspecified
Conditions
Interventions
Intervention 1: Intervention group: Whole wheat flatbread. Intervention 2: Control group: Refined wheat flatbread group.
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
25 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1) Abdominal obesity as defined as a waist circumference in women =80 cm and in men =94 cm based on the cutoff measurements of the Middle East (31) 2) Serum triglycerides =150 mg/dl (1.7mmol/l) 3) Serum high-density lipoprotein (HDL) cholesterol <40 mg/dl (1 mmol/L) in men and <50 mg/dl (1.3 mmol/l) in women 4) Blood pressure =130/85 mmHg 5) Fasting plasma glucose (FPG) between 100-125mg/dl (5.6-6.9) mmol/l 6) 25-64 years old
Exclusion criteria
Exclusion criteria: • Individuals with a history of diabetes, Individuals with a history of cardiovascular diseases, Individuals with a history of cancer, Individuals with a history of kidney disease, Individuals with a history of lower gastrointestinal conditions Individuals with a history of celiac disease.• Individuals taking medications which could influence lipid metabolism except for low- intensity Statin therapy, Individuals taking medications which could influence glucose metabolism except for Metformin up to 1000mg/day Individuals taking medications which could influence blood pressuer except for losartan up to 25mg/day Women who are pregnant or may become pregnant during the duration of the study breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood sugar. Timepoint: before intervention and 3,4,7 months after intervention. Method of measurement: by Glucose oxidase method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR). Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: by the following formula: (fastinginsulin (µU/ml)) × fasting glucose (mmol/l))/22.5).;Plasma Total Cholesterol/HDL-C. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: by the formula.;Triglyceride. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: enzymatic method.;Total Cholesterol. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Enzymatic method.;Fasting plasma Insulin. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Elisa.;Postprandial Insulin. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Elisa.;Postprandial glucose. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Glucose oxidase method.;High sensitivity C-reactive protein concentration(hs-CRP). Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Turbidimetric method.;Interleukin1(IL1). Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Enzymatic method.;Interleukin6(IL6). Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the intervention. Method of measurement: Enzymatic method.;Tumor Necrosis Factor-?(TNF-?),. Timepoint: At the beginning of the study(before starting intervention), 3, 4,7 months after the inte | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactFatemeh Kazemi
Tehran University of Medical Sciences
Outcome results
None listed